NCT06734039

Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Med-El Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Detailed description

Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.

Conditions

• Hearing Loss, Unilateral
• Cochlear Implants
• Hearing Loss, Sensorineural
• Single-Sided Deafness (SSD)
• Asymmetric Hearing Loss

Interventions

Type	Name	Description
DEVICE	Programming of cochlear implant audio processor frequency settings	Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software

Timeline

• Start date: 2025-11-10
• Primary completion: 2028-04-01
• Completion: 2028-10-01
• First posted: 2024-12-13
• Last updated: 2026-03-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study